89118
Elemental Impurities according to ICH Q3D parenteral, Standard 1
(in 12% nitric acid), TraceCERT®, applicable for testing acc. to USP<232>, Ph.Eur. Gen. Chapter 5.20
Sinonimo/i:
ICH Q3D Elemental Impurity Analysis Standard
About This Item
Prodotti consigliati
Grado
certified reference material
TraceCERT®
Livello qualitativo
agenzia
according to ICH Q3D
according to Ph. Eur.
according to USP
Nome Commerciale
TraceCERT®
Durata
limited shelf life, expiry date on the label
Composizione
Ag, 10 mg/L
As, 15 mg/L
Cd, 2 mg/L
Co, 5 mg/L
Hg, 3 mg/L
Ni, 20 mg/L
Pb, 5 mg/L
Se, 80 mg/L
Tl, 8 mg/L
V, 10 mg/L
Concentrazione
(in 12% nitric acid)
tecniche
ICP: suitable
Formato
multi-component solution
Descrizione generale
Certified content incl. uncertainty and expiry date are given on the certificate.
Download your certificate at: http://www.sigma-aldrich.com.
Applicazioni
- Application of ICH Guidelines for the Assessment and Control of Elemental Impurities in Parecoxib Sodium by Graphite-Digestion and ICP-MS: This research demonstrates the application of ICH Q3D guidelines for evaluating elemental impurities in parenteral formulations, specifically using graphite-digestion and ICP-MS techniques on Parecoxib Sodium. This approach ensures compliance with pharmaceutical safety standards, emphasizing its critical role in maintaining drug quality and patient safety (Hao et al., 2022).
Nota sulla preparazione
Note legali
Prodotti correlati
Avvertenze
Danger
Indicazioni di pericolo
Classi di pericolo
Eye Dam. 1 - Met. Corr. 1 - Skin Corr. 1B
Rischi supp
Classe di pericolosità dell'acqua (WGK)
WGK 2
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Articoli
Elemental impurities in drug products pose a risk to patient health due to toxicological effects, and their levels should be controlled within acceptable limits. Find analytical methods and materials for impurity assessment.
In 2009, the International Conference on Harmonization (ICH) proposed the development of a new harmonized guideline to provide a global policy for limiting metal impurities in drug products and ingredients. This approach provides clear regulatory guidance on specification limits for elemental impurities worldwide and logically should have an impact on the work of the national regulatory bodies in having transparent and comparable results.
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